Effects of Newly-Initiated QUAD Therapy on Aortic/Coronary Inflammation in ART-Naïve Infected Patients
Completed
Conditions studied: HIV
In brief
The main aims of this study are to determine whether: a) ART-naïve HIV+ subjects have increased artherosclerotic plaque inflammation/vulnerability, b) newly-initiated QUAD/Stribild therapy will decrease plaque inflammation/vulnerability in these subjects, and c) QUAD/Stribild therapy will improve indices of immune dysregulation and lipid dysfunction as a mechanism of improved plaque inflammation/vulnerability. Parameters of lipid and immune function will also be assessed in healthy control subjects, for comparison.
Key facts
- Study ID
- NCT01766726
- Run by
- Massachusetts General Hospital
- People needed
- 33
- Starts
- 2012-12-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2017-03-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- men and women, ages 18+, with documented HIV-infection who are ART-naive and ready to be started on ART with QUAD/Stribild by their treating infectious disease doctors
You may not qualify if…
- history of prior, sustained ART use
- CD4 <50 or AIDS-defining illness
- known current opportunistic infection or acute infections (not including Hepatitis B/C)
- pregnancy or breastfeeding
- history of acute coronary syndrome or coronary artery stenting or surgery, diabetes mellitus, or significant autoimmune/inflammatory disease
- plans for sustained use during 6 month study interval of a confounding immune suppressant medication including intravenous or oral corticosteroid
- hemoglobin < 12.5 g/dl for men or < 12 g/dl for women
- eGFR < 70 ml/min/1.73 m2 calculated by CDK-EPI
- contrast dye allergy
- contraindication to beta blockers or nitroglycerin administered during MDCT coronary angiography (coronary CTA) protocol
- body weight > 320 lbs (PET scanner limitation)
- significant radiation exposure (>2 myocardial perfusion scans or CT angiograms) received within the past year
- reported active illicit drug use
- Healthy control subjects:
- Inclusion Criteria:
- men and women, ages 18+, without HIV infection
- Exclusion Criteria:
- known current opportunistic infection or acute infections (not including Hepatitis B/C)
- pregnancy or breastfeeding
- history of acute coronary syndrome or coronary artery stenting or surgery, diabetes mellitus, or significant autoimmune/inflammatory disease
- sustained use of a confounding immune suppressant medication including intravenous or oral corticosteroid
- hemoglobin < 12.5 g/dl for men or < 12 g/dl for women
- reported active illicit drug use
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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